Canadian life science clinical research and manufacturing capabilities
An important trend in the global pharmaceutical industry over the last decade has been to externalize drug R&D programs and manufacturing, including via partnerships with academia, small and medium sized enterprises (SMEs), government research centres as well as specialized research and manufacturing organizations. As part of this trend, Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) have become an essential part of the life science value chain, by offering comprehensive services to speed up product development plans and increase manufacturing efficiency. It is estimated that 60% of innovator small molecules and 82% of innovator biologics have their roots in research carried out outside of big pharmaceutical companies over the past decade, with manufacturing and service organizations playing an increasingly important role in supporting the growth of emerging biotechnology companies in areas that include stem cell research and engineering biology, and by providing essential support in meeting stringent regulatory reviews. This profile of Canadian CMOs and CROs provides an overview of the services of a few select Canadian organizations.
| Company | AccelLAB Inc. | BRI Biopharmaceutical Research Inc. | CiToxLAB |
| Description | Your partner of choice for preclinical safety and efficacy testing of medical devices in the fields of cardiology and orthopaedics. | BRI Biopharmaceutical Research Inc. is a specialized analytical, bioanalytical and drug metabolism and pharmacokinetics contract research organization (CRO) servicing pharmaceutical and biotechnology companies in discovery, preclinical and clinical programs supporting IND (Investigational New Drug) and NDA (New Drug Application) enabling studies. | CiToxLAB is a one-stop-shop CRO in laboratory sciences investigations, including bioanalysis and biomarkers investigations |
| Animal Models | ✔ | ✔ | ✔ |
| Trial and Protocol Design | ✔ | ||
| Ethics & Regulatory Submissions | ✔ | ||
| Other | Cardiology; Medical Devices; Orthopaedics | Bioanalytical services; CMC; Pharmacokinetics | Bioanalytical services; Carcinogenicity; Immunology; Pharmacokinetics; Pharmacology; Toxicology |
| Company | ITR Laboratories Canada Inc. | NuChem Therapeutics | Nucro-Technics |
| Description | ITR Laboratories Canada is an accredited GLP-compliant non-clinical CRO specializing in multi-species animal efficacy model, laboratory support services and toxicological evaluations for all types of molecules and immunotherapy platforms. | NuChem Therapeutics is a synthetic chemistry and biology contract research organization located in Saint-Laurent, Montreal. The company provides integrated services to early drug discovery projects for our clients spanning from in silico chemistry, organic synthesis, medicinal chemistry, ADME/PK, Biochemistry, cell biology and in vivo pharmacology, in the area of small molecule drug discovery. | Nucro-Technics is a full-service Contract Research Organization that specializes in providing services to organizations that engage in drug research and have compounds in their pipeline at the preclinical and clinical stage . |
| Animal Models | ✔ | ✔ | ✔ |
| Trial and Protocol Design | ✔ | ✔ | |
| Ethics & Regulatory Submissions | ✔ | ||
| Other | Bioanalytical services; Materials; Preclinical trials; Product development; Statistics and data management; Strategic consulting | Bioanalytical Services; Chemistry (Medicinal, Synthetic and/or Organic) | Bioanalytical services; Proteomics; Toxicology |
| Company | Allphase | Altasciences | AzadMedica Inc. | BioPharma Services Inc. |
| Description | Allphase provides clinical development strategy and management services for early-stage to post-market programs, including the management of clinical studies and regulatory affairs. | Altasciences are a forward-thinking, mid-size early phase contract research organization, in Canada and the U.S., offering biopharmaceutical companies of all sizes a proven, flexible approach to early drug development, including preclinical safety testing, clinical pharmacology (Phase I / II), bioanalysis (preclinical to Phase IV), research services, and manufacturing and analytical services. Focused on your success … always available and always looking ahead. Moving in unison to deliver big impact with a personal touch. | As a CRO with regional/national/global reach, AzadMedica Inc. provides expertise in healthcare intelligence to support pharmaceutical & biotechnology and medical device companies taking their assets from concept to market, merging its research expertise, data insights, and patient perspective to address clinical development challenges with insights and impacts. AzadMedica provides access to a Virtual Clinical Research Site, and its data scientists combine project outcomes and technology information to offer data visualization in a format that transforms the way research is done. |
Bio Pharma is a full-service CRO focused on providing Phase I/IIa and bioequivalence clinical services to pharmaceutical and biotech companies around the world. Support services include regulatory and scientific affairs, PK design and support, medical writing, data management, biostatistics, and bioanalytics. |
| Phase I | ✔ | ✔ | ✔ | I-IIa |
| Phase II-III | ✔ | ✔ | ✔ | |
| Phase IV | ✔ | ✔ | ||
| Regulatory Counselling | ✔ | ✔ | ||
| Other | Trial and Protocol Design; Preclinical Trials; Animal Models; Medical Writing; Bioanalytical Services; Statistics and Data Management; | Medical Writing; Product Development; Statistics and Data Management; Strategic Consulting; Trials and Protocol Design | Alcohol and DD-Interaction; FIH; Human abuse liability; SAD/MAD |
| Company | CIRION | Clinical Development Solutions | CRM Pharma Consulting Inc. | Diex Research |
| Description | CIRION is GLP contract research lab of two core services: R&D (specializing in the area of large molecules and biomarkers) and global central laboratory (specializing in the global logistical and project management services of multi-site clinical trials). | An experienced and innovative CRO, CDS provides strategic consulting and hands-on clinical development and regulatory support, and clinical trial execution; specializing in cardiovascular, metabolic, oncology, and all areas of early stage medicinal product development. | CRM Pharma Consulting Inc. provides services in clinical research, regulatory and medical affairs, with expertise in management and planning of programs for drugs, biologics, devices, cell therapies and nutraceuticals. Services include preparation of regulatory submissions to Health Canada, development and management of investigator run trials, management of multi center global clinical trials from site selection to publication, training of physicians and health care providers in GCPs and clinical research. | Founded in 2006, the DIEX group manages 3 different research centers in Canada. With over 350 trials completed over the years, DIEX has the element of success needed in the industry and many ways to accommodate to its clients’ needs for the conduct of phase II-III trials |
| Phase I | ✔ | ✔ | ||
| Phase II-III | ✔ | ✔ | ✔ | ✔ |
| Phase IV | ✔ | ✔ | ✔ | |
| Regulatory Counselling | ✔ | ✔ | ||
| Other | Bioanalytical services; Biology; Biomarkers; Biosimilar; Central lab; Materials; preclinical trials; Stats and data management; Trial and protocol design | ISO Certifications; Monitoring; Pharmacovigilance; Project management; QA; Scientific and medical writing | Medical writing; Project management; Regulatory consulting; Strategic consulting; Trials and protocol design |
| Company | Episome | ethica CRO | JSS Medical Research | McDougall Scientific |
| Description | Episome is a life science advisory and Medical Affairs services company, combining expertise with medical launch experience for strategic guidance and resources to facilitate Canadian and International launch success. | ethica CRO Inc. helps small to mid-tier international pharmaceutical, biotechnology and medical device companies achieve credible and reliable data that the public can trust by providing end-to-end clinical research and medical communications services according to accredited standards and procedures. ethica CRO is the first accredited CRO in the world and an industry leader in ethical research. | Canadian-global CRO, with offices in Canada, the US, Poland, India and Colombia. More than 30 years in the market and over 200 projects executed in the last year. | Since 1984, McDougall Scientific has earned its reputation as one of the most experienced CROs and is proud to deliver valuable insight for clients in a wide variety of therapeutic areas across. |
| Phase I | ✔ | ✔ | ✔ | |
| Phase II-III | ✔ | ✔ | ✔ | |
| Phase IV | ✔ | ✔ | ✔ | ✔ |
| Regulatory Counselling | ||||
| Other | Medical Writing; Strategic Consulting; Trials and Protocol Design | Medical Writing; Statistics and Data Management; Trials and Protocol Design | Bioanalytical services; Late-stage clinical materials; Market access; Medical devices; Medical writing; Nutraceuticals; Product development; Statistics and data management; Strategic consulting; Trial and protocol design | eTMF; Medical writing; Statistics and data management; Strategic consulting |
| Company | Medicor Research Inc. | MedQualis | PAREXEL International Corporation |
| Description | Medicor manages clinical trials, medical research and medical device development in most therapeutic areas in the physician’s office, out-patient clinics, in-hospital and in-house, meeting the unique needs of both the principal investigator and sponsor. | MedQualis is a full-service CRO providing all the clinical research services (Bioequivalence and biosimilars services included) with a proven expertise in data management and biostatistics to the pharmaceutical, biotech, medical device, biologics, and natural health product industries. | PAREXEL International Corporation is the world’s leading innovator of biopharmaceutical services, helping their clients transform scientific discoveries into new medical treatments for patients with high-quality Phase I-IV clinical research, regulatory consulting and market access services. PAREXEL leverages its comprehensive therapeutic, technical and functional expertise, and industry knowledge in over 100 countries. |
| Phase I | ✔ | ✔ | ✔ |
| Phase II-III | ✔ | ✔ | ✔ |
| Phase IV | ✔ | ✔ | ✔ |
| Regulatory Counselling | |||
| Other | Medical devices | Biometrics | AI; Big data; Bioanalytical services; consulting; Data management; materials; Medical writing |
| Company | Stiris Research Inc. | Syreon | Trial Management Group Inc. | Vantage BioTrials |
| Description | Stiris Research is an entrepreneurial Clinical Trial Management company providing Phase I through IIIB full-service support to Biotechnology and Biopharmaceutical companies. | Syreon is a leading technology-driven Clinical Research Organization combining elite biomedical sciences, advanced information technologies and global trial networks to speed the evaluation of new drugs, diagnostics and medical devices and guide safe, effective and cost-efficient clinical use. | TMG Research is experienced in the design and execution clinical trials that
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Vantage BioTrials is a CRO providing Phase I-IV clinical trial management services to international pharmaceuticals, biotechnology and medical device companies. Vantage are experts in implementing Risk-Based Management through the use of Quality by Design methodologies, which helps accelerate the conduct of a study, reduce risk and ensure the trial is performed correctly. |
| Phase I | ✔ | ✔ | ||
| Phase II-III | ✔ | ✔ | ||
| Phase IV | ✔ | ✔ | ✔ | |
| Regulatory Counselling | ✔ | |||
| Other | Project Management; Study Feasibility; Clinical Monitoring; Risk-Based Monitoring; Biostatistics/Data Management; Patient Travel Services; Rescue Trial Services; Regulatory Services; Pharmacovigilance; Medical Monitoring; Medical Writing; Scientific Affairs Consulting; Quality Assurance; Auditing Services | Clinical trials; Health economics; Health outcomes; Precision medicine; Real-world evidence. |
Medical devices | Medical devices; Medical writing; QA auditing; Statistics and data management; Strategic consulting; Study rescue; Trials and protocol design |
| Company | Biodextris | BioVectra | Corealis Pharma |
| Description | Biodextris is a CDMO providing bioprocess development, non-GMP bio manufacturing, analytical assay development and GMP-compliant QA services, with a focus on vaccine and biotherapeutics programs. | BioVectra is a Contract Development and Manufacturing Organization (CDMO) that serves global pharmaceutical and biotech companies with full-service cGMP outsourcing solutions for intermediates and active pharmaceutical ingredients. | Corealis offers formulation development and clinical supply manufacture of pharmaceutical oral solid dosage forms for international submissions. With in-house access to R&D and GMP compliant operations, Corealis professionals commit and deliver on agreed-upon dates and budgets. |
| Product Development | ✔ | ✔ | ✔ |
| Preclinical and Phase I Materials | ✔ | ✔ | ✔ |
| Late-stage Clinical Trials Materials | ✔ | ||
| Commercial Production | ✔ | ||
| Other | Analytical method development/qualification/validation; GMP; Process development | Biologics; Bioprocessing Reagents; Complex chemistry; Formulation development; Microbial fermentation | Clinical supply manufacturing; Formulation development |
| Company | Dermolab Pharma | Norgen Biotek Corporation | Toronto Research Chemicals |
| Description | Dermolab Pharma designs, manufactures and packages cosmetic, pharmaceutical and natural health products for its customers throughout North America. | Norgen Biotek is a Canadian biotechnology company focused on developing products for sample collection, sample preparation and sample detection, as well as providing comprehensive research services to the scientific community. We have extensive experience in OEM and contract manufacturing of kits and reagents for the molecular biology and diagnostics markets. In addition to developing and manufacturing molecular biology products, Norgen Biotek provides comprehensive R&D services. Our facility features a state-of-the-art cleanroom, high-throughput filling machines, full development labs and an Illumina Propel certified Next-Generation Sequencing laboratory.; | Toronto Research Chemicals manufactures more than 90,000 research chemicals and complex organic chemicals for biomedical and pharmaceutical research |
| Product Development | ✔ | ✔ | ✔ |
| Preclinical and Phase I Materials | ✔ | ✔ | |
| Late-stage Clinical Trials Materials | ✔ | ||
| Commercial Production | ✔ | ✔ | |
| Other | Trial and Protocol Design; Preclinical Trials; Bioanalytical Services; Statistics and Data Management | Analytical services; Chemical and customized syntheses |
| Company | CanAm Bioresearch Inc. | GL Chemtec | NAEJA-RGM |
| Description | CanAm Bioresearch Inc. is a CRO specializing in difficult synthetic chemistry/medicinal chemistry drug development | Since 2002, GL CHEMTEC has provided contract chemistry to the pharmaceutical and biotechnology sectors, from discovery to scale-up. | NAEJA-RGM is heavily involved in the discovery of new molecules to treat various disease areas with specific emphasis on the discovery of antimicrobial agents designed to treat infections caused by drug resistant organisms. |
| Product Development | ✔ | ✔ | |
| Preclinical and Phase I Materials | ✔ | ✔ | |
| Late-stage Clinical Trials Materials | |||
| Commercial Productions | |||
| Other | Chemistry/Synthetic | Medical device prototypes | Chemistry (Organic/Synthetic ) |
| Company | OmegaChem | ||
| Description | OmegaChem is a CRO engaged in organic chemistry. The company is providing innovative products and contract services to the pharmaceutical and biotechnology industry from R&D discovery to chemical process optimization. | ||
| Product Development | ✔ | ||
| Preclinical and Phase I Materials | ✔ | ||
| Late-stage Clinical Trials Materials | |||
| Commercial Productions | ✔ | ||
| Other | Custom synthesis; FTE services; Chemistry; Organic chemistry; Process chemistry |
| Company | AXSource | International Food Focus Ltd. | RaQa Consulting Inc. |
| Description | AXSource is a consulting and technology company providing Regulatory & Quality and IT Advisory services. Services include in global clinical, regulatory, compliance, quality assurance, quality control, and IT business solutions to the pharmaceuticals, biologics, medical devices, cosmetics, healthcare, information technology, clinical laboratories and allied industries. | International Food Focus Ltd. provides regulatory compliance services to the food and allied industries in the USA, Canada and the EU. Their expertise spans the life-sciences umbrella and includes pre-commercialization and post-commercialization. | RaQa Consulting Inc. specializes in obtaining regulatory approvals and quality compliance for pharmaceuticals, natural health products, medical devices and cosmetic products in Canada and global markets |
| Ethics and regulatory services | ✔ | ✔ | ✔ |
| Medical writing | ✔ | ||
| Accreditations | Research Ethics Board/Institutional Research Board Approval | Regulatory Affairs Certification (RAC) | |
| Other | GCP; GLP; GMP; GVP services and audits | Regulatory pre-market submissions: Canada, USA, EU; Strategic consulting | Strategic consulting; import/export; quality compliance and GMP; project management |
| Company | SPharm | ||
| Description | SPharm is a Canadian CSO specialized in strategic regulatory affairs and health product development services. SPharm assists pharmaceutical, biotechnology, natural health products, medical device companies and more, from around the world throughout the various phases of development. | ||
| Ethics and regulatory services | ✔ | ||
| Medical writing | ✔ | ||
| Accreditations | |||
| Other | eCTD publishing; pre-clinial and Phase I materials; Product development, Strategic consulting; Translation |
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